- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04867603
Digital PET/CT Using [Ga-68]PSMA for Characterization of Prostate Lesions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Individuals with clinical suspicion of prostate cancer and without prior prostate biopsy are offered abbreviated bi-parametric prostate MRI. As Standard of Care (SOC), MRIs will be examined and scored for likelihood for malignancy using the PI-RADS version 2.1 criteria. Those with PI-RADS 3, 4 or 5 lesions or those with PI-RADS 1 or 2 lesions with clinical suspicion for prostate cancer based on serum PSA level, family history or clinical examination (positive digital rectal examination) will be included on study. Only those receiving care at University Hospitals Cleveland Medical Center will be included into the study.
This study is to evaluate ([Ga-68]PSMA) for characterization of prostate abnormalities. For imaging, an FDA approved imaging technology, digital Positron Emission Tomography (PET/CT) will be used. The study team would like to know if digital PET/CT using [Ga-68]PSMA provides accurate information whether or not a participant has prostate cancer and if there is potential spread of the disease within the body. [Ga-68]PSMA is an investigational (experimental) drug that works by binding to Prostate Specific Membrane Antigen (PSA), which is overexpressed in prostate cancer. [Ga-68]PSMA is experimental because it is not approved by the Food and Drug Administration (FDA). However, FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44106-5065
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who have a clinical suspicion of prostate cancer defined by PI-RADS 3, 4 or 5 lesions detected on MRI as well as patients with negative prostate MRI or those with PI-RADS 1 or 2 lesions if they have continued suspicion for prostate cancer. Patients who cannot undergo MRI imaging but have a clinical suspicion for prostate cancer based on serum PSA level, family history or clinical examination (positive digital rectal examination) can also be included.
- Able to tolerate PET/CT scans
- Informed consent must be given and signed
Exclusion Criteria:
- Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
- Known allergy against Ga-68 PSMA
- Prior prostate biopsy within the last 2 weeks
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Digital PET/CT using [Ga-68]PSMA
Following prostate Standard of Care MRI, eligible participants will receive a single injection of [Ga-68]PSMA followed by digital PET/CT imaging approximately 60 minutes later.
PET/CT takes approximately 30-35 minutes, where the participant would lay still on a scanner table.
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The injectable activity will be a maximum of 210 MBq (6.0 mCi) [Ga-68]PSMA at the time of injection and is administered to subjects by intravenous injection.
PET/CT imaging procedure
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
True positive rate
Time Frame: During scan, up to 35 minutes
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Diagnostic performance of digital PET/CT using [Ga-68]PSMA for characterization of prostate lesions, as measured by true-positive rate.
The uptake of [Ga-68]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland.
The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up.
Subsequent histopathology will be used as the reference standard.
If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
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During scan, up to 35 minutes
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False positive rate
Time Frame: During scan, up to 35 minutes
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Diagnostic performance of digital PET/CT using [Ga-68]PSMA for characterization of prostate lesions, as measured by false-positive rate.
The uptake of [Ga-68]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland.
The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up.
Subsequent histopathology will be used as the reference standard.
If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
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During scan, up to 35 minutes
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True negative rate
Time Frame: During scan, up to 35 minutes
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Diagnostic performance of digital PET/CT using [Ga-68]PSMA for characterization of prostate lesions, as measured by true negative rate.
The uptake of [Ga-68]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland.
The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up.
Subsequent histopathology will be used as the reference standard.
If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
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During scan, up to 35 minutes
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False negative negative rate
Time Frame: During scan, up to 35 minutes
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Diagnostic performance of digital PET/CT using [Ga-68]PSMA for characterization of prostate lesions, as measured by false negative rate.
The uptake of [Ga-68]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland.
The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up.
Subsequent histopathology will be used as the reference standard.
If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
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During scan, up to 35 minutes
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Sensitivity
Time Frame: During scan, up to 35 minutes
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Diagnostic performance of digital PET/CT using [Ga-68]PSMA for characterization of prostate lesions, as measured by sensitivity.
The uptake of [Ga-68]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland.
The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up.
Subsequent histopathology will be used as the reference standard.
If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
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During scan, up to 35 minutes
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Specificity
Time Frame: During scan, up to 35 minutes
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Diagnostic performance of digital PET/CT using [Ga-68]PSMA for characterization of prostate lesions, as measured by specificity.
The uptake of [Ga-68]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland.
The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up.
Subsequent histopathology will be used as the reference standard.
If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
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During scan, up to 35 minutes
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Positive predictive value (PPV)
Time Frame: During scan, up to 35 minutes
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Diagnostic performance of digital PET/CT using [Ga-68]PSMA for characterization of prostate lesions, as measured by (PPV).
The uptake of [Ga-68]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland.
The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up.
Subsequent histopathology will be used as the reference standard.
If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
|
During scan, up to 35 minutes
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Negative predictive value (NPV)
Time Frame: During scan, up to 35 minutes
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Diagnostic performance of digital PET/CT using [Ga-68]PSMA for characterization of prostate lesions, as measured by (NPV).
The uptake of [Ga-68]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland.
The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up.
Subsequent histopathology will be used as the reference standard.
If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
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During scan, up to 35 minutes
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Proportion of prostate lesions determined to be cancer determined by [Ga-68]PSMA compared to histopathology
Time Frame: During scan, up to 35 minutes
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Quantitative data collected from PET biomarker ([Ga-68]PSMA) uptake will be used to analyze prostate lesions for differentiation between benign prostate changes and prostate cancer.
Differentiation prostate lesion by PET biomarker will be compared to histology reference standard.
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During scan, up to 35 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determination of prostate lesion aggressiveness using Gleason scores
Time Frame: During scan, up to 35 minutes
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Uptake of ([Ga-68]PSMA) will be compared with the Gleason score, which is a grading system used to determine the aggressiveness of prostate cancer.
Scores range from 2 to 10, with higher scores indicating worse outcomes (more likely that the cancer will grow and metastasize)
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During scan, up to 35 minutes
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Determination of prostate lesion aggressiveness using prostate grading system scores
Time Frame: During scan, up to 35 minutes
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Uptake of ([Ga-68]PSMA) wil be compared with the prostate grading system score, which is an extension of the current Gleason grading scale for determining the stage and aggressiveness of prostate cancer. This system is designed to provide a simplified and more accurate grading stratification system than the current Gleason Score. Scores range from 1 to 5, with higher scores indicating worse outcomes |
During scan, up to 35 minutes
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Average pre-test PSA level
Time Frame: During scan, up to 35 minutes
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Average pre-test PSA level will be measured and reported.
Ability of digital PET/CT using [Ga-68]PSMA uptake to identify malignant prostate lesions will be explored by plotting PSA levels against diagnostic performance of PET/CT using [Ga-68]PSMA, with histopathology serving as the reference standard.
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During scan, up to 35 minutes
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Proportion of metastatic lesions identified by digital PET/CT using [Ga-68]PSMA compared to reference
Time Frame: During scan, up to 35 minutes
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Focally increased [Ga-68]PSMA uptake within the torso PET images will be compared with standard of care clinical imaging to verify the presence of metastatic lesions.
In addition, patient follow up and histopathology will be used as reference if available.
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During scan, up to 35 minutes
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optimized image reconstruction parameters - Voxel size
Time Frame: During scan, up to 35 minutes
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The acquired datasets from digital PET/CT using [Ga-68]PSMA will be reconstructed in different voxel sizes and by using dedicated reconstruction parameters affecting the noise levels of the images. Optimized image reconstruction parameters will be identified, including "voxel size" and "image quality" - Voxel size: 4x4x4mm, 2x2x2mm, 1x1x1mm |
During scan, up to 35 minutes
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Optimized image reconstruction parameters - Image quality
Time Frame: During scan, up to 35 minutes
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The acquired datasets from digital PET/CT using [Ga-68]PSMA will be reconstructed in different voxel sizes and by using dedicated reconstruction parameters affecting the noise levels of the images. Optimized image reconstruction parameters will be identified, including "voxel size" and "image quality" - Image quality, assessed via visual analysis focused on the separation of anatomical structures (.e.g. delineation of the pelvis) and abnormal findings, e.g. increased tracer uptake within the prostate gland |
During scan, up to 35 minutes
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Optimized acquisition and reconstruction parameters of digital PET - Image quality
Time Frame: During scan, up to 35 minutes
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Acquired PET/CT data sets will be reconstructed using different algorithms including respiratory and cardiac motion. The impact of variation in acquisition and reconstruction parameters on quantification of PET images will be assessed as well, Including "image quality" and "iterations and subsets" - Image quality, assessed via visual analysis focused on the separation of anatomical structures (.e.g. delineation of the pelvis) and abnormal findings, e.g. increased tracer uptake within the prostate glan |
During scan, up to 35 minutes
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Optimized acquisition and reconstruction parameters of digital PET - Iterations and subsets
Time Frame: During scan, up to 35 minutes
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Acquired PET/CT data sets will be reconstructed using different algorithms including respiratory and cardiac motion. The impact of variation in acquisition and reconstruction parameters on quantification of PET images will be assessed as well, Including "image quality" and "iterations and subsets" - Iterations and subsets are part of the Iterative Reconstruction used for PET image reconstruction. Ordered subsets methods group projection data into an ordered sequence of subsets (or blocks). An iteration of ordered subsets EM is defined as a single pass through all the subsets, in each subset using the current estimate to initialize application of EM with that data subset. |
During scan, up to 35 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Norbert Avril, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE1821
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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